Our client is a multinational pharmaceutical company that excels in discovering, developing, and producing innovative medical solutions and animal health products. Operating worldwide, they collaborate with healthcare professionals, governments, and organizations to address medical gaps, ensure financial integrity, and offer precise financial data, thus enabling informed decisions and regulatory compliance.
As a Regulatory Affairs Specialist, you’ll join our team of Regulatory Affairs Product Managers at Global Regulatory Affairs Biologicals. Your core role will revolve around helping create crucial regulatory documents.
Within the team, your primary duty will be to update product information for all biological products in the European Union. Your focus will be on maintaining the accuracy and quality of these regulatory submissions. You will also play a role in the licensing of new products and the continuous regulatory upkeep of existing biological products.
– Ensuring timely and high-quality preparation and management of scientific dossiers for licensing new products and maintaining existing ones, including variations and renewals.
-Skillfully handling and submitting top-notch responses to regulatory inquiries during the licensing process.
-Active participation in meetings with authorities to discuss regulatory and technical aspects of new submissions and address questions.
-Maintaining a deep understanding of relevant regulatory requirements.
-Assisting in the development of regulatory strategies for both new and existing biological products to ensure effective management and compliance.
-Academic background, preferably with a Ph.D. or equivalent 5 years of experience in biomedical sciences, such as virology, bacteriology, molecular biology, or veterinary sciences.
-Prior experience in the pharmaceutical industry, with a focus on product development and/or maintenance, along with regulatory expertise, particularly in the area of biological products, is advantageous.
-Proficiency in communication and negotiation skills is essential.
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